Ignite Creation Date:
2025-12-18 @ 9:55 AM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT05523414
Status:
None
Last Update Posted:
2025-05-04 00:00:00
First Post:
2022-08-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of SKY Breath Meditation on Health and Well-being
Sponsor:
None
Organization:
Study Overview
Official Title:
A Pilot Feasibility Study to Evaluate the Effect of SKY Breath Meditation on Health and Well-being
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will recruit up to 60 participants in the SKY intervention and up to 60 participants in the control group. Recruitment is expected to take up to a year. After providing informed consent, participants will be randomly assigned to the SKY intervention group, or a waitlist control group. Interventions will be performed in-person in San Diego.
Prior to interventions, each participant will be asked to fill out behavioral questionnaires containing surveys and standardized cognitive measurements. Participants will be also asked to provide blood samples for biological assays (epigenetics, transcriptomics and proteomics). All participants will be scheduled for the questionnaire data collection and specimen collection up to two weeks preceding the start of either intervention. Participants will be asked to wear a Garmin vivoSmart5 smartwatch to collect physiological measures.
The SKY intervention will be administered in-person over three sessions over three consecutive days. All participants (SKY and control) will be asked to provide a second blood sample at the end of the third session of the SKY intervention. SKY participants will then engage in a remotely administered follow-up over up to eight weeks' time with the option to attend daily remotely-led breathwork sessions for 30 minutes. Participants will be asked to log daily practice engagement using online surveys through the eight-week follow-up period. Reminders will be provided to the participant intermittently during this time. During the period of eight weeks, the participants will return for 1-hour in-person follow-up SKY sessions once a week. They will be required to attend at least 75% of these weekly sessions. After 8 weeks of follow up, participants will provide a third sample of blood, and perform a post-intervention questionnaire.
Control participants will also have a similar schedule of data and biological sample collection as the SKY group. Waitlist controls will be provided the opportunity to attend the SKY retreat free of charge at the conclusion of the follow up period.
Prior to interventions, each participant will be asked to fill out behavioral questionnaires containing surveys and standardized cognitive measurements. Participants will be also asked to provide blood samples for biological assays (epigenetics, transcriptomics and proteomics). All participants will be scheduled for the questionnaire data collection and specimen collection up to two weeks preceding the start of either intervention. Participants will be asked to wear a Garmin vivoSmart5 smartwatch to collect physiological measures.
The SKY intervention will be administered in-person over three sessions over three consecutive days. All participants (SKY and control) will be asked to provide a second blood sample at the end of the third session of the SKY intervention. SKY participants will then engage in a remotely administered follow-up over up to eight weeks' time with the option to attend daily remotely-led breathwork sessions for 30 minutes. Participants will be asked to log daily practice engagement using online surveys through the eight-week follow-up period. Reminders will be provided to the participant intermittently during this time. During the period of eight weeks, the participants will return for 1-hour in-person follow-up SKY sessions once a week. They will be required to attend at least 75% of these weekly sessions. After 8 weeks of follow up, participants will provide a third sample of blood, and perform a post-intervention questionnaire.
Control participants will also have a similar schedule of data and biological sample collection as the SKY group. Waitlist controls will be provided the opportunity to attend the SKY retreat free of charge at the conclusion of the follow up period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: